A Phase IIa Trial Evaluating the Efficacy of anti-CD19 Chimeric Antigen Receptor Engineered T-Cells in Patients With Systemic Sclerosis (SSc) Resistant to Immunosuppressive Drugs. SCLEROCAR
Key facts
- Where
- Lille, Montpellier Cedex 5 és Paris, FranciaországSee the 3 sites
- Phase
- 2. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Franciaország
- Centre Hospitalier Universitaire de LilleLille, FranciaországTaking people
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranciaországTaking people
- Assistance Publique Hopitaux de Paris – Hopital CochinParis, FranciaországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier Universitaire De Montpellier
- Trial code
- EU 2024-519511-33-00
- Record updated
- 2026. október 12.
- Original description
To evaluate the clinical efficacy of the CAR T ANTI-CD19 cell therapy on skin fibrosis assessed by mRSS score month 6 after CAR T ANTI-CD19 cell administration in patients with systemic sclerosis resistant to immunosuppressive drugs.Read full original descriptionShow less
To evaluate the clinical efficacy of the CAR T ANTI-CD19 cell therapy on skin fibrosis assessed by mRSS score month 6 after CAR T ANTI-CD19 cell administration in patients with systemic sclerosis resistant to immunosuppressive drugs.
Inclusion: Diagnosis of systemic sclerosis according to ACR/EULAR classification; Refractory corresponds to patients with active disease (as defined by EUSTAR ≥2.5) and to patients with a worsening disease despite 6 months of at least 2 immunosuppressive treatments including one DMARDs (methotrexate, azathioprine, mycophenolate mofetil), and one biological DMARD rituximab or tocilizumab; Age: ≥18 ≤65 years old; Adequate organ functions assessed within 4 weeks of inclusion:; Adequate venous access for apheresis; Leucapheresis : a wash-out period of 6 weeks for conventional immunosuppressants (i.e. methotrexate, mycophenolate mofetil); Leucapheresis : at least 3 months after biotherapy (i.e. tocilizumab, 6 months for rituximab),.
Exclusion: Live vaccines within 30 days prior to leukapheresis; Craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia or cerebrovascular hemorrhagic diseases; patients with advanced cognitive disorders or any other cause preventing their informed consent; Lung and / or heart severe dysfunction defined by CVF<50% and/or DLCO <40%; Pulmonary arterial hypertension defined by catheterism (mean AP > 25mmHg at rest or > 30mmHg after exercise, PAPO < 15mmHG); Active infection (including but not limited to: hepatitis B or C virus or HIV) or covid-19 < 1 months; ECG showing prolonged QT interval or history of severe heart diseases or FEVG < 40%; pregnant or breastfeeding women; Active hematological or solid neoplasm; Methylprednisolone or prednisone (≤20 mg) instead of immunosuppressive agents; Rituximab within 6 months to leukapheresis.